MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/0; HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE

Catalog Number	17-3200E
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding wear involving a ceramic head was reported.The event was confirmed by mar.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 16 aug 2018.Images of the device are included in the mar.{.} the returned device is shown in figures 1 and 2.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.{.} {.} the articulating surface of the head is shown in figures 5 and 6, with a wear scar being observed.The wear scar is likely due to contact against a ceramic surface.{.} the material analysis report concluded: {.} based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.{.} medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant confirmed stem fracture; however, did not reference the ceramic head wear observed during mar.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, surgical implant records from the surgeries, dated pre and post op x-rays/ imaging from the index and revision surgeries and outpatient office/clinic notes are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
The customer reported that the patient presented with pain and x-ray confirmed that his exeter stem had fractured at the neck, requiring revision.Mar confirms wear of the ceramic head.

• Brand Name: ALUMINA C-TAPER HEAD 32MM/0
• Common Device Name: HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8032481
• Report Number: 0002249697-2018-03594
• Device Sequence Number: 16440926
• Product Code: LZO
• UDI-Device Identifier: 07613327101249
• UDI-Public: 07613327101249
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K971409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 17-3200E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR